Conditioned medical testing

ABSTRACT

The invention refers to a computer implemented method, a computer system a test machine and a computer program product for executing conditioned and qualified test. An ordering instance may order a set of tests, comprising an initial test and a set of follow-up tests, wherein the execution of each of the follow-up tests is dependent of the result of the respective predecessor test, like the initial test. The conditions for executing the follow-up tests are dynamically definable and are analyzed automatically.

TECHNICAL FIELD

The present invention mainly refers to the field of informationtechnology and medical technology. Particularly, it refers to acomputer-implemented method, a computer-implemented system, a computerprogram product and a test machine, being computer-controlled within ahospital or clinical computerized information system.

BACKGROUND OF THE INVENTION

Usually, clinical facilities comprise of a lot of different clinicaldepartments. For a patient's treatment, typically, an inter-departmentalworkflow is thus necessary, as different clinical entities have tointeract with each other and a clinical workflow between differentclinical departments is a very complex task. Therefore, there is a highpotential for decreasing cost and increasing quality by improvingefficiency of this workflow. The interface between specific departmentscan benefit very much from intelligent computerized interface systems.Particularly, the radiology department and the central laboratory(shortly: lab) show interdependencies for which an interfacing workflowcould be ameliorated with respect to efficiency and also with respect toother parameters, like cost aspects.

In a typical clinical workflow, nowadays, during an initial patientinvestigation a physician develops a first hypothesis for a possiblediagnosis and needs further data in order to support his hypothesis. Thestrategy in most cases is to start with relatively cheap methods, forexample with IVD tests (in vitro diagnostic tests) and to escalate tomore expensive methods, for example magnet resonance imaging or the likein a later phase of the diagnostic process.

Typically, the physician orders a set of lab parameters to test hishypothesis. Subsequently, the test is going to be executed in order togather the lab parameters for the physician. Then, the physicianreceives the result with the lab parameters and analyzes whether or notthis result may confirm his hypothesis. In case that his hypothesismight be confirmed and he needs to have further data, the physicianmight escalate the workflow in order to get subsequent IVD tests or toinitiate diagnostic imaging for gathering more information. In case thathis hypothesis might not be confirmed, he has to formulate a newhypothesis and he possibly orders a new set of lab parameters. In thiscase, subsequently another lab test will be ordered and started.

The above mentioned procedure is time-consuming and error-prone, sincethe lab tests might be initiated iteratively and a sequence of testingand analyzing is necessary. Therefore, in present systems it may taketwo or more days for a final clarification of a patients disease,because the initialization of each subsequent step within the clinicalworkflow requires a written consent of involved medical staff(physician, radiologist, laboratory personal, other specialist etc.).

DESCRIPTION OF PRIOR ART

In present prior art systems, process steps being related to a firstdepartment are normally being executed isolated from and independent ofprocess steps, being related to a second medical department. There is achain of personal decisions from the respective physicians.Particularly, each laboratory test needs to be ordered or confirmed bythe physician. Automated software support is only used within localdevices, but not within an inter-departmental workflow and thus, notacross the interface of hospital departments.

US 2006/0210435 discloses a method for automatically analyzing anexecuted laboratory test. However, this system is only to be used withinthe laboratory department and could not be used for communication withother departments and clinical institutions.

Therefore, there is a need for an automated support system for adecision taking with respect to laboratory tests and follow uplaboratory tests and generally with respect to a test workflow.

SUMMARY OF THE INVENTION

Abstractly stated, the present invention is a computer-implementedmethod and system that allows for an optimization of a clinical testworkflow with respect to efficiency. Particularly, the present inventionallows for a conditioned testing, wherein a result of the respectivetest is analyzed. Based on this analysis there is a decision alreadywithin the testing laboratory department whether or not to initiate afollow-up test.

In the following the present invention will be described with respect tothe method. Any aspects, features or advantages mentioned in thisrespect might also be applied to the other categories of the claims (forexample to a system according to the invention and also to the computerprogram product according to the invention). With other words the systemand the product might also be adapted to incorporate features, havingbeen mentioned with respect to the description of the method accordingto the invention. Any functional feature refers to an apparatus feature,having the respective functionality.

For example the step of “receiving an order” refers to a “reception unitwhich is adapted to receive orders and interfaces with other (ordering)departments”. Further, the step of “executing the received at least onetest” refers to a structural entity of the apparatus, which is used as“execution unit” for executing the test, wherein the execution unit maybe arranged within or integrated in a test machine.

Particularly, the present invention refers to a computer-implementedmethod for implementing a set of tests, comprising the following steps:

-   -   receiving an order for at least one test;    -   automatically executing the received at least one test;    -   receiving a result of the executed at least one test;    -   analyzing the result in order to determine whether at least one        follow-up test needs to be executed and if yes:        -   automatically generating an order for the at least follow-up            test and iteratively executing the steps for the at least            one follow-up test.

In the following, there is given a short explanation or definition ofterms, used within this disclosure.

“Implementing” a set of tests is to be construed in the sense ofgenerating or establishing an information technological clinicalprocess, which might comprise a plurality of testing steps. A clinicaltest usually consists of a sequence of testing steps or test elementsand might be controlled by a clinical workflow. Sometimes differentprocess elements might be executed subsequently or in parallel. Eachprocess step within the test has to be linked to other process stepsand, thus, show interdependencies. Further, interdependencies also existwith respect to other clinical departments. For example, depending onthe result of an image acquisition process within a clinical department,different clinical tests have to be initiated.

It is contemplated that the method and the system of the presentinvention is suitable for implementing a set of clinical laboratorytests. However, the invention is not limited to laboratory tests and italso might be applied to other clinical processes within a clinicalworkflow or taskflow, like image acquisition processes, administrativeprocesses, for example, with respect to a scheduling of relevant deviceslike imaging acquisition modalities, administrative processes withrespect to clinical personal, processes within different clinicaldepartments, cost related processes, billing systems etc. Usually, thereis not only one single test, but a set of tests that has to be carriedout.

The “order” for a test might be generated manually and might exist inpaper form or, preferably, might be generated by means of a computerizedtool and might be confirmed by a respective confirmation signal by thephysician which might be forwarded to the laboratory department.Typically, the order consists of a set of testing parameters. Theseparameter refer to testing conditions, information and meta-informationwith respect to the specific patient, time information, etc. One ofseveral major aspect of the present invention is to be seen in that theorder may also comprise rules. The rules may refer to specific testingconditions and to the result of the test which might serve as a basisfor possible follow-up tests. Abstractly stated, for example followingorder might be given:

“order for test A: in case the result of test A is “−”→no furthertesting; in case the result of test A is “+”→executing a follow-up testB”.

Thus, there could be a cascade of tests, wherein the result of anearlier or predecessor test is the basis for the decision with respectto follow-up actions or with respect to the execution of a follow-uptest.

According to one aspect of the present invention there is a conditionedtesting. In case the presumptions for a follow-up test are given, thisfollow-up test is initiated and executed automatically. No furtherinteraction with the ordering instance (the ordering physician etc.) isnecessary anymore. The physician, however, might still be informed aboutthe result and about the decision for follow-up testing. This leads tothe advantage of efficiency enhancement and failure reduction.

According to one aspect of the present invention receiving the result ofthe executed test is done within the testing department. Additionally,the result of the executed test might also be forwarded to the orderinginstance, i.e. to the radiology department or any other departmentwithin the clinic. However, this forwarding is not necessary anymore forthe execution of follow-up tests. Also, analyzing the result of the testis also done within the testing department. Usually, analyzing theresult of the test comprises receiving the result, comparing the resultwith given (pre-determined or user set) rules, values or parameters.Analyzing further might comprise an access to one or differentdatabases, for example relating to diagnostic devices or imagingmodalities within the hospital, relating to scheduling of devices, toavailability analysis, to cost related aspects, to a billing systemand/or relating to clinical guidelines. Analyzing automaticallygenerates a decision whether or not to initiate a follow-up test. Incase a follow-up test needs to be executed an order for a follow-up testis generated automatically and the steps of the method mentioned aboveare carried out again for the follow-up test. Thus, there might be asequence or a cascade of tests and follow-up tests, wherein theexecution of a test depends on the result of a specific predecessortest.

Analyzing particularly comprises an access to a rule database. In therule database there are stored rules with respect to the specific tests,to the result of the tests and to possible follow-up actions withrespect to these results or to conditions for executing follow-up tests.In a preferred embodiment analyzing also could comprise the step ofnotifying a user about possible inconsistencies with clinical guidelinesor with other clinical knowledge. This might be the case, if a test isordered although it might not be indicated due to general clinicalguideline knowledge.

According to a further aspect of the present invention analyzing furthercomprises notifying the user about the result of the test. Thisnotification might comprise additional information in case the test saysthat certain standard values are not given. For example the user mightbe notified about an extension of certain limits, for example “bloodpressure too low” or “blood pressure too high”. These notificationsmight be sent to other instances within the clinical workflow in orderto inform about the test result.

According to one of the key aspects of the present invention the resultof the test is analyzed with respect to further testing actions, i.e.for initiating of a follow-up test. Thus, there might be implemented aconditioned workflow of testing, wherein the condition is analyzedautomatically and wherein a further testing (follow-up testing) is alsoinitiated and executed automatically, without the necessity ofinteraction with the ordering instance. However, according to analternative embodiment the execution of a follow-up test is dependent ofa confirmation signal of an ordering instance. In the latter case themethod automatically generates a suggestion for a follow-up test,wherein the execution of this suggested follow-up test is only executedin case a confirmation signal has been received. In any case, however,the suggestion for follow-up actions (like one single follow-up test, asequence of a follow-up tests, a further user interaction, a patient'sinterview or other actions) is generated automatically. A methodaccording to the present invention might be executed iteratively for alltests and follow-up tests.

According to a preferred embodiment of the present invention the testand/or the follow-up test might be based on different clinicaldepartments. For example a first test might relate to a laboratory test,whereas a second test might relate to an image acquisition within theradiology department. Thus, according to the present invention aworkflow might be automatically generated that relates to differentclinical departments.

According to a further aspect of the present invention the test and/or afollow-up test might be based on the same or on different test samples.According to a preferred embodiment the same sample is used for the testand for all of the follow-up tests, if possible. This has the advantage,that it is only necessary to take one blood sample of the patient.However, it might also be the case, that a follow-up test needs to becarried out on a further sample. In this case the respectivenotification for the medical staff is generated automatically.

According to yet another aspect of the present invention analyzing theresult is based on aspects, selected from:

-   -   the received result of a predecessor test or other earlier        tests;    -   medical meta-information;    -   medical knowledge, definable in rules;    -   user input    -   context situation.

As already mentioned above, analyzing might comprise a database accessto look-up predefined parameters, compare values or guidelinespecifications.

According to a further aspect of the present invention the steps of thecomputer-implemented method might be executed iteratively. This meansthat in a first session there is received an order for an initial test;this initial test will be executed automatically; the result of thisinitial test is received and analyzed within a test unit itself in orderto decide if a first follow-up test for the initial test is necessary ornot. In case a first follow-up test is necessary, there is generated anorder for the first follow-up test. Then, this first follow-up test isexecuted automatically as second action. In case the result of thisfirst follow-up test leads to another second follow-up test, also this(second) follow-up test will be executed automatically. After eachexecution and analysis of the respective result there might be anautomatic initiation of a possible third follow-up test and so on.

According to a preferred embodiment a user might interrupt thisautomatic execution of tests and follow-up tests by a respectiveinterruption signal. According to another embodiment of the presentinvention the follow-up tests are not executed automatically, but theyare only executed after having received a user confirmation.

According to another aspect of the present invention the workflow forthe set of tests might be dynamically structured. For example it mightbe possible, that a user defines time-related parameters for theexecution of the test and/or the follow-up tests. For example the usermight set that the follow-up test needs to be executed immediately afterhaving received an order of the follow-up test. Alternatively, the usermight define that a follow-up test is only to be executed under certainpreconditions or circumstances. For example it might be set that eachfollow-up test is only to be executed after a certain preparation phase.The time-related parameters and the time schedule are dynamicallyadaptable.

According to another aspect of the present invention the test and/or thefollow-up test might be executed subsequently or—if possible—inparallel. A parallel execution of different tests might be implementedif there were more than one testing device for the same test or ifdifferent tests had to be carried out.

In case a further sample for a follow-up test needs to be taken, arespective user notification will be generated automatically.

Preferably, the result of the test and/or the follow-up test and theresult of the analyzing process are stored in a storage medium, i.e. adata base, related to the testing device or in a central storage.

According to another aspect of the present invention also statisticalinformation is gathered, so that this statistical information might beused for next tests. For example, the statistical rule might be: “Afterexecution of test A, in 95% of cases follow-up test B will beinitiated”. This statistical information might be used and accessedduring analyzing the result of the respective test and for generating anautomatic suggestion for next actions to be taken.

According to further aspect of the present invention it is not necessarythat a physician inputs an explicit order for a test. Alternatively theorder for the test might be deduced, based on a user input. The userinput might be a hypothesis, an alternative hypothesis, a clinicalquestion, or any other more abstract input information. Based on thereceived input, an order for the respective test will automatically bededuced. The deduction of the respective test is based on a ruledatabase. For example the rule database might comprise a certainclinical question and a set of clinical tests to be carried out in orderto answer the clinical question.

According to yet another aspect of the present invention the methodimplements an event-based or result-based workflow of tests, wherein thetest is dependent on a result of the respective predecessor test or isdependent on an analysis of the respective predecessor test.

Thus, there is provided an intelligent software tool with improvedconnectivity between different clinical departments, in order tominimize the number of separate action items within the clinicalworkflow. Further the clinical workflow might be optimized with respectto time-related aspects and/or with respect to cost-related aspects orin relation to any other pre-definable parameters.

For example in case an ordering physician orders are specific lab testthe invention proposes the following situation: Instead of sending theresult of the lab test (or of any other test machine) back to theordering physician the laboratory test is automatically analyzed withinthe laboratory device according to the present invention. This is asignificant enhancement as, in most of the cases, a next action stepmight directly and automatically be derived by the laboratory systemitself or by the treating physician in advance (before ordering thefirst lab test). According to the invention in most of all cases thetreating physician needs not to interpret the result of the tests andneeds not to decide manually for the next action step. This is executedautomatically or semi-automatically, supported by a computer systemaccording to the present invention.

According to the invention there exist two mechanisms which might beused separately or in combination of each other.

According to the first mechanism the lab system has access to a patienthistory and to previous diagnostic findings of the patient viaconnectivity to electronic patient record data in the HIS (HospitalInformation System). As mentioned above according to the presentinvention the result of the test is analyzed automatically. Further, theresult might be compared with other patient-related data, electronicpatient records and with other statistical information in order toautomatically derive the most optimal next diagnostic test step. Thesuggestion for the most optimal next diagnostic test step is generatedand outputted. Preferably, this next test action which has been analyzedas being most optimal in the actual situation is initiatedautomatically.

According to the second mechanism the ordering physician delivers inaddition to an ordered parameter set the actually preferred hypothesisplus alternative hypothesis. Based on the result of the test, the systemaccording to the invention automatically develops a strategy how toconfirm the first hypothesis, being given by the physician. In case thefirst hypothesis is disproved, the alternative hypothesis is analyzed.In case further user interaction is necessary, the user is notified witha respective message over the user interface.

As already mentioned above, the physician might explicitly input anorder for a test. Alternatively, the physician might input a fixed setof lab parameters, to be tested. This might be done within a graphicaluser interface and a respective representation of a set of possible testparameters. The user then selects specific parameters out of therepresented set of parameters. Further, alternatively, the physiciandoes not need to input a fixed set of lab parameters, but poses aclinical question like “Inflammation Assessment” to the lab departmentand leaves it to the expert system according to the present invention toautomatically determine the best set of lab parameters to beinvestigated for answering this clinical question. This assessment mightbe done by accessing a rule database. The assessment is then carried outautomatically.

According to a further aspect of the present invention the treatingphysician does not input only one test, which has to be executed andanalyzed according to the present invention, but he inputs a set oftests. Further, he may input conditions for analyzing the result of thetest and/or for executing follow-up tests. Thus, the treating physicianis able to already order at least one subsequent testing depending onthe result of the initial or predecessor test (for example a Troponintest and a subsequent CK-MB follow-up test in case “Troponin is high”).

According to another aspect of the present invention an alternativereimbursement model might be introduced. In present state of the artsystems there is a one-to-one relation between ordered lab parametersand incurred costs. Instead of this one-to-one relation, the costs andthe payment might be related to the answer of a diagnostic hypothesisonly and the laboratory department decides by itself what set ofsubsequent laboratory tests have to be executed to answer the question.For a more detailed cost breakdown scheme the way towards a finalestablishment of a diagnosis might be described by a decision treecontaining several levels of subsequent decision nodes and wherein thereimbursement is based on a “fee per progress” along the levels of thedecision tree. This reimbursement can be implemented with the healthcare insurances, but also for internal purposes within the hospital.

According to a further embodiment the method according to the inventionmight be extended by an optimization module. The order of tests isdecided on diagnostic relevance versus cost related aspects. Further,the decision might be based on statistical values and might be combinedwith a risk percentage or what is the confidence level of the results ofthe respective tests. The optimization parameters might be definable. Incase of conflicts with respect to optimization parameters, there couldbe defined specific rules. For example the clinical result shouldoverrule the cost decision in case of conflicts.

As an advantage an effectiveness of the method according to theinvention may be measured automatically. Further, it is possible to givea cost estimation for all tests and also for tests which are planned tobe ordered, already in an early stage beforehand. Therefore, thephysician gets an overview of the costs incurred beforehand. Further,the costs incurred with the old testing scheme according to the state ofthe art might be compared to the costs, incurred with the testingscheme, being optimized according to the present invention.

As all data is stored, a monitoring of the method according to thepresent invention is possible. Further, this (statistical) knowledge(for example in most of all cases follow-up test B is executed afterinitial test A has been carried out) might be fed back to the systemagain so that the expert system is able to learn. Further, clinicalguidelines might be adapted according to this knowledge.

According to another aspect the present invention relates to acomputer-implemented system for implementing a set of tests. The systemcomprises a reception unit, an execution unit, an analyzing module andan iteration unit. The system interacts with the different clinicaldepartments, i.e. with the laboratory department and with radiology.Further, the system has a user interface for inputting and outputtingdata.

In a preferred embodiment the computer-implemented system is an expertsystem. Preferably, the analyzing module of the system is directlyintegrated into an automated IVD-Analyzer or into another test machine,so that the decision for follow-up tests can be made before the bloodsample leaves the analyzer with very low costs, compared to a state ofthe art workflow, where the sample first is transported into a storagearea and then put back into the analyzer for repeated testing, in casethe physician orders a follow-up test.

According to another aspect the present invention is related to a testmachine for executing clinical tests, comprising a test module, which isadapted to execute the method for implementing a set of tests, which hasbeen described above. The execution unit might be integrated into a testmachine (modified according to the present invention) or might beprovided as add-on module for conventional test machines or analyzers,respectively.

As mentioned above, according to a preferred embodiment the system isrealized as an add-on module, which might be switched on to existingtest machines or analyzers in the laboratory department. The systemprovides a further functionality for testing, so that also a conditionedtesting and a workflow for a sequence of tests might be definable andexecutable automatically.

According to yet another aspect of the present invention the systemon-line calculates the cost efficiency of follow-up tests, based on adatabase, relating to costs and based on experiences from former tests.If, for example, the costs for getting a sample back from storage is 5Euro and the costs for follow-up testing is 1 Euro and the likelihoodthat a follow-up test is ordered in this special case has been 50% inthe past, the suggestion would be that it is most cost efficient to dothe follow-up test directly in the analyzer instead of waiting for anadditional order for the follow-up test from the ordering physician.

According to another aspect the present invention refers to a computerprogram product or a computer program having computer executableinstructions for executing the method, mentioned above, if that programis loaded onto a computer, wherein the method is adapted forimplementing a set of tests. The computer program product or the programmight be stored on a computer-readable medium.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic overview of an example of a system according tothe present invention and according to a preferred embodiment and

FIG. 2 is a flowchart according to a preferred embodiment of the methodaccording to the present invention.

DETAILED DESCRIPTION OF THE DRAWINGS

Embodiments of a method of the present invention are describedhereinafter. In the following description, meaning of specific detailsis given to provide a thorough understanding of embodiments of theinvention. One skilled in the relevant art will recognize, however, thatthe invention can be practiced without one or more of the specificdetails, or with other methods, modules, entities etc. In otherinstances, well-known structures, computer related functions oroperations are not shown or described in detail, as they will beunderstood by those skilled in the art. Also, it will be understood thatthe steps of the method have not necessarily to be executed in still thesame order possibly might be executed in a different order iftechnically possible. Further, not all steps of the method need to beexecuted on the same computer (module) Accordingly, some steps of themethod might be executed on the same or on other modules.

Further, the method is described with respect to medical testing.However, it is apparent that also other actions or any other kind ofpatient's treatment or medical data processing might also be applied andprocessed, respectively.

Reference throughout this specification to “one/an embodiment” meansthat a particular feature, structure or characteristic described inconnection with the embodiment is included in at least one embodiment ofthe present invention. Thus, the appearances of the phrases “accordingto one embodiment” or the like in various places throughout thisspecification are not necessarily all referring to the same embodiment.Furthermore, the particular features, structures or characteristics maybe combined in any suitable manner in one or more embodiments.

FIG. 1 shows a schematic overview of the context for a system 100 of thepresent invention according to a preferred embodiment. Differentclinical departments interact with each other. In this case theradiology department R interacts with the laboratory department L(shortly: lab). In other embodiments, also other departments areinvolved in this interaction. Possibly, an administrative unit or anyother units may be combined into this interaction. As can be seen inFIG. 1 the lab L comprises a test machine T which is adapted to executelaboratory tests, which have been ordered by an ordering instance, whichin the example in FIG. 1 is the radiology. Test machine T might comprisea carousel with respective recesses for engaging with sample bottles oralternatively might be any other kind of testing assembly. The orderinginstance for the respective test might be the laboratory L itself ormight be any other department, like oncology, which has a respectiveinterface with the laboratory L.

In contrast to the state of the art systems the present inventionprovides an automated order system for clinical tests, wherein aqualified and conditioned ordering might be selected. For this reason asystem 100 is connected ahead or at the input of the test machine T. Thesystem 100 has a testing interface to the test machine T (which in FIG.1 is depicted by a vertical arrow between tester T and execution unit 12of system 100), an input interface with other departments (which in FIG.1 is depicted by an arrow between radiology R and reception unit 10 ofsystem 100) for receiving an order for the test and possibly also mighthave a user interface UI and an access to databases DB.

Generally, the specific use and application of the test machine T mightvary or might be coupled (connected via internet or intranet) to othertesting machines. For example, a first test machine might be adapted forblood testing, liquid testing, blood pressure testing and/or blood sugartesting, a second test machine might refer to liver testing whereas athird test machine might be directed to an image acquisition withdifferent modalities, like MRT, CT or ultrasonic image acquisition etc.In FIG. 1 a test machine T is depicted with test tubes for receiving andanalyzing samples for an IVD testing.

The system 100 preferably is computerized and comprises a set of units,which themselves might be implemented as software modules or as hardwaremodules as well or as a combination thereof. The system 100 comprises areception unit 10, an execution unit 12, an analyzing module 14 and aniteration unit 16.

In FIG. 1 an example of the system 100 is depicted, in which all units10, 12, 14, 16 are provided within the system 100. However, it is alsopossible that at least one of the units 10, 12, 14, 16 is provided asexternal instance which communicates with the system 100 over arespective interface. In FIG. 1 the database DB is depicted as externalinstance which might be accessed by the analyzing module 14 of thesystem 100. In an alternative embodiment it is also possible that thedatabase DB is part of the system 100.

The reception unit 10 is adapted for receiving and/or placing an orderfor the test from/to an ordering instance, which might be the radiologydepartment R. In a first embodiment the reception unit 10 itself has theinterface to the radiology department R, whereas in a second embodimentthe system 100 has the interface to the radiology R.

The execution unit 12 is adapted for automatically initiating the test,which has been received by the reception unit 10. Therefore, theexecution unit 12 has an interface to the test machine T or it isintegrated into the tester T. Preferably, the input interface of thesystem 100 and the testing interface to the test machine T are adaptedfor transmitting parameters for testing. These parameters might concerncontext parameters which are relevant for testing. For exampleparameters might be volume of the sample, testing conditions liketemperature, standard values, contrast parameter values, and any othermeta-information which might be relevant for execution of the test. Theexecution unit 12 is further adapted to automatically start therespective test on the test machine T, after having received the orderfor the test via the input interface. In the preferred embodiment nofurther user interaction is necessary anymore. Alternatively, thetesting on the test machine T might be initiated semi-automatically. Inthe latter case a user confirmation signal, which might be inputted overthe user interface is necessary for executing the test on the testmachine T. In this case the user gets an additional possibility tocontrol the testing process.

After the test has been executed on the test machine T the result ofthis test is sent via the test interface to the system 100 again. Theanalyzing module 14 is adapted for receiving the result of the executedtest and analyzes the result. Preferably, analyzing might be adapteddynamically for specific testing context situations. Preferably,analyzing is done in order to determine whether at least one follow-uptest needs to be executed or not. Analyzing does not necessarily requirea user input and also might be executed automatically. Analyzing mightfurther comprise an access to the database DB, for example, forcomparing the test result with specific standard values. Moreover,analyzing might also access specific data which have been transmittedvia the input interface from the ordering instance R. Possibly theseparameters indicate that the ordering instance wishes a follow-up testto be executed. The order for a follow-up test might be generated duringgeneration of the order for the test itself or also might be generatedafterwards. This aspect is a major advantage over present state of theart systems, as at least one follow-up test (there might be generatedseveral follow-up tests for one initial test), might be generatedalready during ordering the first (initial) test. This also is a majoradvantage over known systems as a recirculation of the sample is notnecessary in case a set of tests have to be carried out on the samesample. Efficiency, therefore, might be ameliorated significantly.

However, according to a preferred embodiment it is not necessary that afollow-up test order is already generated by the ordering instance Rduring generation of the test order itself. Particularly, the follow-uptest order might also be generated automatically by the system 100itself. For this reason the analyzing module 14 and the iteration unit16 interact with a rule database (not shown in FIG. 1) for deducingpossible follow-up test orders. For example the rule database mightcomprise rules like:

“If testing is ‘leucocytes’ and ‘test result is not within standardvalues’→‘follow-up test needs to be executed for testing blood sugar’”.

The rule database might be dynamically adaptable according to actualmedical knowledge. Further, the rule database also might accessstatistical values. Statistical values, for example, might indicate thatin 80% of the case a follow-up test for “blood sugar” is executed afterhaving executed the tests “blood cells” or “blood coagulation”. Alsothis statistical values will be considered by analyzing whether or not afollow-up test needs to be executed.

In case a follow-up test turns out to be necessary, a respective orderfor a follow-up test will be generated and sent to the execution unit 12for automatically initiating the follow-up test on the test machine T.

The iteration unit 16 is adapted for automatically generating an orderfor at least one follow-up test, in case such a follow-up test needs tobe executed. The order for the follow-up test then will be forwarded tothe execution unit 12 to be transmitted to the test machine T.

Preferably, the system 100 according to the present invention may beimplemented in any suitable network system, like client-server systems,local area networks, wide area networks or alternate types of internetwork. Moreover, anyone of a variety of client-server architecture may beused, including but not limited to TCP/IP(HTTP-network) orspecifications like NAS or SAA. All modules and units of the system 100may be interconnected by a bus system. Further, there might be used acentral or several databases DB for storing and retrieving data relatedto the implementation of the testing process. Thus, the network mayinclude a plurality of devices, such as a server, routers and switchingcircuits connecting in a network configuration, as known by a personskilled in the art.

The user of the system 100 may use a computer device, such as a personalcomputer, or a personal digital assistant or any other computerizeddevices for interacting with the system 100. Access to other networkmodules and servers might be executed by using wireless or wiredcommunication protocols. The computer device might be coupled toI/O-devices (not shown in FIG. 1) that may include a keyboard incombination with a pointing device, such as a mouse to input data intothe computer, a computer display screen and/or a printer to produce anoutput of the system 100. The output might be forwarded over the inputinterface to the ordering instance R or might be outputted via userinterface UI to the user again. Also both modalities for outputting theresult might be applied. Additionally, the output might be forwarded toa printer to have it in paper form and possibly might be forwarded to astorage resource, such as the database DB or to any other repository orhard disc drive for storing and retrieving data.

The invention further provides another solution which is to be seen in amodification of a conventional test machine T, known in the state of theart. In this case a software module and/or a hardware module, adapted toimplement the system 100 according to the present invention is/areincorporated into the test machine T.

With respect to FIG. 2 the flowchart according to the method will bedescribed hereinafter more detailed. However, this flowchart has to beconstrued as being an example of a possible workflow and might bemodified respectively.

In a first step meta-data are provided. Meta-data might refer tohistorical or actual anamnesis data for the patient, administrative datawith respect to the patient, medical personal data for the patient'streatment, meta-data with respect to the patient, like sex, age, family,treatment history etc. Meta-Data, therefore, might refer to the patient,to testing conditions and/or to the treatment context of the patient.

In case a blood test needs to be carried out a blood sample will betaken, which is depicted in FIG. 2 as second step.

After having taken the blood sample, in a third step, the order for theblood test is generated by the ordering instance R.

In a fourth step there is an automatic execution of the ordered bloodtest. The order for the test is received by the reception unit 10 andwas forwarded to the test machine T by means of execution unit 12.

After having executed the blood test the result of the blood test isanalyzed in a fifth step. If the result indicates that there is nostroke risk, the result is reported to the ordering instance R, which isdepicted on the left hand side on FIG. 2. Otherwise, in case the resultindicates a stroke risk, there are automatically deduced further actionsto be taken for further treatment of the patient. These further actionmight be a follow-up test, a report to the physician, the initiation ofother clinical actions or a combination thereof.

In the example, depicted in FIG. 2 there needs to be carried out afollow-up test for testing “blood sugar”. Then, the order for the(first) follow-up test will be automatically generated. Further, the(first) follow-up test will be executed automatically by the testmachine T. After having executed the (first) follow-up test, the resultis analyzed within the system 10 again. In case the result indicates nostroke risk, the result will be reported to the physician, as explainedabove. Otherwise, if the result indicates a stroke risk, a further(second) follow-up test will be automatically ordered. For example afurther (second) follow-up test might be directed to testing“kidney/liver metabolism”. The order for the second follow-up test willbe forwarded to the test machine T, so that the test machine T willautomatically execute the further (second) follow-up test. The furtherfollow-up test will then be received by the system 100 again foranalyzing the same. Depending on the result of the further follow-uptest further actions differ respectively. If the result indicates thatthere is no stroke risk, then the result will be reported to thephysician or to the ordering instance R as being depicted on the lefthand side of FIG. 2. Otherwise, if the result indicates a stroke risk,there might be generated a final diagnosis. Usually, a final diagnosismight be executed after having sent the result of the further follow-uptest to the physician, so that the physician may decide for one of threealternatives: “No stroke”, “Bleeding stroke” and “Ischamic Stroke”.These threes alternative diagnoses will lead to alternative treatmentsfor the patient.

As can be seen in FIG. 2 there is a qualified decision for takingfurther actions in a testing environment, based on the result of therespective predecessor test. Depending on the result of a test, therewill be a decision for initiating further steps. Further steps might beseen in initiation and execution of a follow-up test, initiation andexecution of a set of follow-up tests, a report to the orderinginstance, a report to the treating physician or forwarding the resultsto another clinical instance.

In the example, depicted in FIG. 2 the ordering physician only generatesa “simple” or basic order for a blood test. This order only contains theinformation “Blood Test”. No further conditions and requirements aregiven. In another example the ordering physician might generate a morecomplex order. In the latter case the order might comprise additionalinformation. Additional information might be seen in meta-informationwith respect to the test, parameters for testing, conditions forfollow-up tests or a combination thereof. For example it might bepossible that the ordering physician generates a conditioned order,like: “Execution of blood test. In case that the result of bloodtest=“Stroke Risk”→follow-up test “Blood Sugar” has to be carried outautomatically”.

In case of conditioned ordering, the order comprises conditions forexecuting follow-up tests. A level for specifying the set of follow-uptests might be set dynamically. With other words the user might onlyinitiate one level of further testing, i.e. one follow-up test,depending on the result of the respective predecessor test.Alternatively, it may also specify a second level of testing, i.e.specifying a further and second follow-up test, after having executedthe follow-up test and depending on the result of the follow-up test.With other words, this sequence of steps comprising automatic generationof the order, automatic execution of the test, which has been orderedand automatic analyzing of the result of the executed test may beexecuted iteratively, so that several levels of testing might beinitiated and executed automatically.

The system 100 will be monitored, so that the database DB might beupdated respectively. As mentioned above, the preferred embodimentrelates to the execution of laboratory tests by means of the testmachine T. However, any kind of clinical examinations and respectivefollow-up examinations lie within the scope of this invention. The ruleswhich might be accessed during analyzing will be updated according torecent cases. New rules might be incorporated into the rule database.New rules might be incorporated upon confirmation by a physician beforeentering the database DB.

A system 100 according to the invention might directly be integratedinto an automated IVD-Analyzer T so that a decision for follow-up testscan be made before the blood sample leaves the analyzer.

According to a preferred embodiment the system 100 on-line calculatescost efficiency of follow-up tests, based on the database DB, which alsoaccesses cost-related information and experiences from former tests.

The above description of illustrated embodiments of the invention is notintended to be exhaustive or to limit the invention to precise formsdisclosed. While specific embodiments of, and examples for, theinvention are described herein for illustrative purposes variousequivalent modifications are possible within the scope of the inventionand can be made without a deviating from the spirit and scope of theinvention.

Further, the method might be implemented in software, in coded form.Alternatively, it is possible to implement the method according to theinvention in hardware or hardware modules. The hardware modules are thenadapted to perform the functionality of the steps of the method.Furthermore, it is possible to have a combination of hardware andsoftware modules.

These and other modifications can be made to the invention with regardof the above detailed description. The terms used in the followingclaims should not be construed to limit the invention to the specificembodiments disclosed in the specification and the claims. Rather, thescope of the invention is to be determined entirely by the followingclaims, which are to be construed in accordance with establisheddoctrines of claim interpretation.

The invention claimed is:
 1. A computer implemented method forimplementing a set of tests, the method comprising: receiving an orderfor at least one test; determining a workflow for the at least one testbased on one or more events or results, the workflow including one ormore rules, the rules indicate one or more testing conditions, the oneor more testing conditions indicating if at least one follow-up test isto be executed; automatically executing the received at least one test;receiving a result of the executed at least one test; analyzing, by acomputer processor, the result to determine whether the at least onefollow-up test needs to be executed and if yes: automatically generatingan order for the at least one follow-up test without additionalinteraction from an entity the order for the at least one test isreceived from, and iteratively executing the steps for the at least onefollow-up test.
 2. The computer implemented method according to claim 1,wherein at least one of the tests of the set of tests and the follow-uptest are based on different clinical departments.
 3. The computerimplemented method according to claim 1, wherein at least one of thetest and the follow-up test of the set of tests are based on the same oron different samples.
 4. The computer implemented method according toclaim 1, wherein analyzing the result is based on aspects selected fromthe received result of the respective predecessor test, medical metainformation, medical knowledge, definable in rules, and user input. 5.The computer implemented method according to claim 1, wherein applyingthe steps iteratively for at least one follow-up test includesautomatically executing the test, receiving the result for the test, andanalyzing the result.
 6. The computer implemented method according toclaim 1, wherein one of the at least one follow-up test is executedautomatically and prior to executing the at least one follow-up test auser confirmation is received.
 7. The computer implemented methodaccording to claim 1, wherein executing one of the received at least onetest and the at least one follow-up test is done one of immediatelyafter having received the order, at a pre-definable and selectable timeschedule.
 8. The computer implemented method according to claim 1,wherein the at least one test and the at least one follow-up test areexecuted in parallel.
 9. The computer implemented method according toclaim 1, wherein the result of at least one of the at least one test andof the at least one follow-up test are fed back.
 10. A computerimplemented method for implementing a workflow for tests, the methodcomprising: receiving an input; based on the received input, deriving atleast one test; determining a workflow for the at least one test basedon one or more events or results, the workflow including one or morerules, the rules indicate one or more testing conditions, the one ormore testing conditions indicating if at least one follow-up test is tobe executed; automatically executing the at least one test; receiving aresult of the executed at least one test; analyzing, by a computerprocessor, the result in order to determine whether the at least onefollow-up test needs to be executed for responding to the input withoutadditional interaction from an entity the input is received from; forthe at least one follow-up test iteratively executing the steps:automatically starting, receiving the result, analyzing, therebyimplementing a workflow as a result-based cascade of tests, wherein arespective test are dependent on a respective result of a respectivepredecessor test.
 11. A computer implemented system for implementing aset of tests, the system comprising: a reception unit to receive anorder for at least one test; an execution unit to execute the receivedat least one test by means of a test machine; a rules module todetermine a workflow for the at least one test based on one or moreevents or results, the workflow including one or more rules, the rulesindicate one or more testing conditions, the one or more testingconditions indicating if at least one follow-up test is to be executed;an analyzing module to receive a result of executed at least one testand adapted for analyzing the result in order to determine whether theat least one follow-up test needs to be executed; an iteration unit togenerate an order for an at least one follow-up test without additionalinteraction from an entity the order for the at least one test isreceived from, in case such a follow-up test needs to be executed andforwarding the order for the at least one follow-up test to thereception unit.
 12. A test machine for executing clinical tests,comprising a computer implemented system according to claim
 11. 13. Anon-transitory memory including computer readable instructions storedtherein, the instructions causing the computer processor to perform thesteps of the method according to claim 1 when the instructions areexecuted on the computer processor.